| Primary Device ID | 10818207025033 |
| NIH Device Record Key | 610e3795-3f4c-46fc-88b2-e582c5c244f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Traxodent Gel Brush Tips |
| Version Model Number | 9007105 |
| Company DUNS | 036623932 |
| Company Name | Vista Dental |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10818207025033 [Primary] |
| KXR | Applicator, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |
| 10818207024968 - Traxodent Gel AlCl - Bulk Syringe Kit | 2025-07-08 |
| 10818207024975 - Traxodent Gel AlCl - Sample Pack | 2025-07-08 |
| 10818207024982 - Traxodent Gel AlCl - Value Pack | 2025-07-08 |
| 10818207024999 - Traxodent Gel AlCl - Refill Kit | 2025-07-08 |
| 10818207025002 - Traxodent Gel FS - Bulk Syringe Kit | 2025-07-08 |
| 10818207025019 - Traxodent Gel FS - Value Pack | 2025-07-08 |
| 10818207025026 - Traxodent Gel FS - Refill Kit | 2025-07-08 |
| 10818207025033 - Traxodent Gel Brush Tips | 2025-07-08 |
| 10818207025033 - Traxodent Gel Brush Tips | 2025-07-08 |